FDA product code · Dental · Class U
OLR: Oral Wound Dressing
OLR is FDA's product code for "Oral Wound Dressing": a Class U device, reviewed by the Dental panel.
510(k) review time for OLR
Across 17 510(k) clearances under OLR decided from 2018-01-01 to 2026-10-06, the median was 177 days from FDA receipt to decision. Half took between 123 and 241 days, and 80% were decided within 251 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 123 |
| Median | 177 |
| 75th percentile | 241 |
| 80th percentile | 251 |
| 90th percentile | 273 |
| Slowest | 404 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OLR in the public FDA record
| 510(k) clearances, all years | 43 |
|---|
Counts of records, not of devices or events. Adverse event reports for OLR are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OLR
No FDA recognized consensus standard cites OLR by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.